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Foot and mouth disease virus recombinant vaccines and uses thereof

Inactive Publication Date: 2011-09-29
MERIAL LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0015]The antigenic polypeptides and fragments and variants thereof can be formulated into vaccines and/or pharmaceutica

Problems solved by technology

In addition, epidemic outbreaks can occur periodically.
The presence of this disease in a country may have very severe economic consequences resulting from loss of productivity, loss of weight and milk production in infected herds, and from trade embargoes imposed on these countries.
In addition, there are risks linked to incomplete inactivation and / or to the escape of virus during the production of inactivated vaccines (King, A. M. Q., ibid).
However, the production of vaccines, antibodies, proteins, and biopharmaceuticals from plants is far from a remedial process, and there are numerous obstacles that are commonly associated with such vaccine production.
Limitations to successfully producing plant vaccines include low yield of the bioproduct or expressed antigen (Chargelegue et al., Trends in Plant Science 2001, 6, 495-496), protein instability, inconsistencies in product quality (Schillberg et al., Vaccine 2005, 23, 1764-1769), and insufficient capacity to produce viral-like products of expected size and immunogenicity (Arntzen et al., Vaccine 2005, 23, 1753-1756).

Method used

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  • Foot and mouth disease virus recombinant vaccines and uses thereof
  • Foot and mouth disease virus recombinant vaccines and uses thereof
  • Foot and mouth disease virus recombinant vaccines and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

Generation and Screening of FMDV-Expressing Duckweed Lines

[0225]Duckweed optimized FMDV P1 and 3C sequences were produced and cloned into the parental plasmid to generate the MerE vectors depicted in FIGS. 6-9. Four independent constructs were designed for the FMDV project. Table 3 summarizes the number of transgenic lines that were generated and screened and FIG. 3 provides a schematic representation of gene structure for the FMDV inserts. Three lines express the P1 capsid+3C protease (MerE01, 3, 4), whereas the other express the P1 capsid antigen alone (MerE02). ELISA and Agilent analyses were used to quantify the expression of the FMDV antigens. Western blots were performed to verify the correct size of expressed proteins (FIG. 12). The highest FMDV serotype A24-expressing duckweed lines, as determined by mRNA analysis and by western blot, were grown in scale vessels to provide biomass for use in characterization and animal studies.

TABLE 3Line generation and further screening of ...

example 2

Expression of FMDV Antigens in Schizochytrium

[0233]Codon-optimized FMDV P1 and 3C genes are cloned into the expression vector pAB0018 (ATCC deposit no. PTA9616). The specific nucleic acid sequence of FMDV gene is optimized for expression in Schizochytrium sp. Additionally, the expression vector contains a selection marker cassette conferring resistance to Schizochytrium transformants, a promoter from the Schizochytrium native gene to drive expression of the transgene, and a terminator.

[0234]Schizochytrium sp. (ATCC 20888) is used as a host for transformation with the expression vector containing the FDMV gene using electroporation method. Cryostocks of transgenic strains of Schizochytrium are grown in M50-20 (described in US 2008 / 0022422) to confluency. The propagated Schizochytrium cultures are transferred to 50 mL conical tubes and centrifuged at 3000 g for 15 min or 100,000 g for 1 hour. The resulting pellet and the soluble fraction are used for expression analysis and in animal...

example 3

Vaccination of Pigs—Safety Assessment

[0235]Three (3) groups of five (5) pigs were vaccinated on days 0 and 21 (D0 and D21) according to the study design (Table 6). Details of the TS6 adjuvant (emulsions) may be found in U.S. Pat. No. 7,608,279 B2 and U.S. Pat. No. 7,371,395 B2 (both to Merial Limited).

[0236]Assessment of Safety. No adverse general / systemic reactions were observed after vaccination, though transient, slight to moderate increases of rectal temperature were observed in all groups. Locally, slight to moderate reactions were observed for the duckweed groups. The vaccines were globally acceptable for all groups.

TABLE 6Vaccination of pigs - study designGroupAntigenDilutionAdjuvantG1MerE01Not dilutedTS6G2MerE01 1 / 10 dilutedTS6G3—Control—

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Abstract

The present invention encompasses FMDV vaccines or compositions. The vaccine or composition may be a vaccine or composition containing FMDV antigens. The invention also encompasses recombinant vectors encoding and expressing FMDV antigens, epitopes or immunogens which can be used to protect animals, in particular ovines, bovines, caprines, or porcines, against FMDV.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims benefit of U.S. provisional application Ser. No. 61 / 313,164 filed Mar. 12, 2010 and U.S. provisional application Ser. No. 61 / 366,363 filed Jul. 21, 2010.FIELD OF THE INVENTION[0002]The present invention relates to compositions for combating Foot and Mouth Disease Virus (FMDV) infection in animals. The present invention provides pharmaceutical compositions comprising an FMDV antigen, methods of vaccination against FMDV, and kits for use with such methods and compositions.BACKGROUND OF THE INVENTION[0003]Foot-and-mouth disease (FMD) is one of the most virulent and contagious diseases affecting farm animals. This disease is endemic in numerous countries in the world, especially in Africa, Asia and South America. In addition, epidemic outbreaks can occur periodically. The presence of this disease in a country may have very severe economic consequences resulting from loss of productivity, loss of weight and milk product...

Claims

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Application Information

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IPC IPC(8): A61K39/12C07K14/415C07K14/405A61P31/12A61P37/04C12N15/82A01H5/00C12N5/10C12N1/13C12P21/00
CPCA61K39/15A61K2039/517C12N15/8258C12N2720/12134A61K2039/55577A61K2039/552A61K2039/55505A61K2039/55561A61K2039/55566A61K2039/5252A61K39/12A61P31/12A61P31/20A61P37/04C07K14/005
Inventor AUDONNET, JEAN-CHRISTOPHEGUO, XUANFEILMEIR, BRADLEY J.TROUPE, KAROLYN MARIEBUBLOT, MICHELCOX, KEVIN
Owner MERIAL LTD
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